Address:1540 WEST THORNDALE AVE.,ITASCA,IL,60143,US
Device Description : The ASK, All surface bonding Kit is intended for use to increase adhesion to nor The ASK, All surface bonding Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth.The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching, when required. The Assure Plus Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ASK Kit is intended for use to increase adhesion to normal, atypical (wet or The ASK Kit is intended for use to increase adhesion to normal, atypical (wet or dry) enamel surfaces (hypocalcified, fluorosed, deciduous enamel, dentin), sandblasted metal (amalgam, gold or stanless steel), porclain, zirconia, composite restorations and acrylic temporary/pontic teeth.The ASK kit contains the Etchmaster 4 Hole Handpiece adapter with both lingual and regular tips for microetching when required. The Unidose (single use) Assure Universal Bonding Resin included will bond to all intraoral surfaces, including zironia. Porcelain conditioner is provided for bonding to porcelain surfaces.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bond Aligner® is intended for use as an orthodontic bonding adhesive for bracket Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials.Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Indications for Use: Bond-a-Braid is intended for use as a lingual retainer wir Indications for Use: Bond-a-Braid is intended for use as a lingual retainer wire for retaining tooth position after orthodontic treatment.6" strands x 10 per tube
Device Class :
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Indications for Use: Bond-a-Braid is intended for use as a lingual retainer wir Indications for Use: Bond-a-Braid is intended for use as a lingual retainer wire for retaining tooth position after orthodontic treatment.This is a single strand for sample evaluation
Device Class : 1
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Bond Aligner® tips are 22 gauge dispensing tips designed for use with the Bond A Bond Aligner® tips are 22 gauge dispensing tips designed for use with the Bond Aligner adhesive. Contains 5 tips per bag.
Device Class :
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Bend A Brushes are intended for use in the application of dental resins, sealant Bend A Brushes are intended for use in the application of dental resins, sealants and etchants to the tooth surface.
Device Class :
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Blue Gel Etchant is intended for use in etching the tooth surface. Product has Blue Gel Etchant is intended for use in etching the tooth surface. Product has high visibility blue color. Product contains BAC (Benzalchromium chloride). 5 gm syringe with 10 tips
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes
Device Description : Intended for use as a device for holding adhesive brush tips or A2/C&C aligner a Intended for use as a device for holding adhesive brush tips or A2/C&C aligner attachment moulds.
Device Class : 1
Duns Number: 113170088
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry o Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. Assure® Universal Bonding Resindoes not require light activation (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer.This is the 4 gm volume..
Device Class : 2
Duns Number: 113170088
Premarket Exempt : No
Prescription Use : Yes